他達(dá)拉非片用于治療男性勃起功能障礙及改善勃起功能障礙合并良性前列腺增生的癥狀和體征，屬臨床常用藥物，也是原研藥品專利到期后多家企業(yè)立項(xiàng)仿制的重點(diǎn)關(guān)注品種之一。結(jié)合歐盟、美國(guó)該品種生物等效性試驗(yàn)指導(dǎo)原則要求，通過(guò)對(duì)近年來(lái)中國(guó)開(kāi)展的他達(dá)拉非片生物等效性試驗(yàn)結(jié)果進(jìn)行總結(jié)、分析，并對(duì)其生物等效性試驗(yàn)審評(píng)中發(fā)現(xiàn)的多種情況提出一般考慮，為他達(dá)拉非片仿制藥研發(fā)中的生物等效性試驗(yàn)提供依據(jù)與參考。

Tadalafil Tablet is used for the treatment of male erectile dysfunction, Erectile Dysfunction combined with symptoms and signs of benign prostatic hyperplasia, which is a common drug in clinic. It is also one of the key drugs which enterprises set up project after the expiration of the original drug patent. Combining with the European Union, the United States tadalafil tablet bioequivalence test guidelines require, summary and analysis based on recent years bioequivalence result in China, and propose general consideration on variety bioequivalence results of review. For tadalafil tablet bioequivalence research and development provid scientific basis and reference.

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